Director, Clinical Laboratory Operations at International AIDS Vaccine Initiative (IAVI)

Key Responsibilities

• Quality Assurance:
• • Development, implementation and monitoring of quality systems for both the internal IAVI Laboratory Operations unit as well as those of site labs selected, including:
    • Ensuring readiness for technical audits
    • Ensure laboratory operations meet regulatory standards and sponsor requirements 
  • Oversee preparation of sites for clinical trials and epidemiology studies.
  • Oversee teams monitoring study progress at site laboratories for the duration of the study/trial.

• Budget & Vendor Management:
  • Development and management of operational budgets with budget managers and clinical teams based on study needs.
  • Oversee the development of and implementation of associated integrated work plans and budgets, ensuring that the resources are allocated and deployed effectively.
  • Review budgets and timelines ensuring integration with the overall clinical trials program.
  • Identification and assessment of vendors to support Lab Operations.
  • Development and review of scope of work, task orders and contracts for vendors.
  • Management and oversight of procurement and vendor governance for a cost-effective and sustainable lab ecosystem. 

• Team Leadership:
  • Building and mentoring a high-performing team, fostering leadership development, and implementing succession planning. 
  • Review and approval of all laboratory related documents for studies being implemented.
• Technology & Data:
  • Leading the adoption of digital systems like LIMS (Laboratory Information Management Systems) and other platforms for enhanced efficiency, data analysis, and performance monitoring. 

• Regulatory Compliance:
  • Ensuring all laboratory activities comply with Good Clinical Laboratory Practice (GCLP) and other accreditations (e.g. ISO 15189) and other relevant regulations and guidelines. 

• Cross-Functional Collaboration:
  • Serve in product development project teams as the laboratory lead.
  • Serving as a key point of contact for CROs, clinical sites, and internal teams, influencing and leading clinical operations outcomes. 
  • Representing IAVI and its partners in various areas such as presenting project progress, achievements, and lessons learned to donors, and other key stakeholders in meetings and conferences.

Education and Experience: 

• A Ph.D. in Immunology or related field and a minimum of 7 years of relevant independent research experience, either in a university or corporate setting, with experience working on clinical trials is required OR;
• A minimum of bachelor’s degree in life sciences or related field and 10 years’ experience in a safety laboratory will also be considered and clinical trials experience in developing countries is required.
• Experience working in a certified or accredited lab is required (e.g CLIA, ISO, CAP and GCLP).

Qualifications and Skills: 

• Experience managing clinical laboratory research projects and staff to deliver high quality data to meet project goals and deadlines is required.
• Broad knowledge of clinical medicine, pathology disciplines, basic medical sciences, clinical laboratory sciences, laboratory operations, and quality management systems required.
• Experience in safety labs analysis and assay validation and verification, as well as assay development and optimization is required.
• Experience and understanding of ICH GCP, GCLP and other relevant regulatory requirements for clinical trials.
• Knowledge of and skills in informatics, data analysis, and business management highly preferred.
• Experience with vaccine clinical trials and assay development is highly preferred.
• Understanding of and experience with implementation of Good Clinical laboratory Practices in infectious disease clinical trials conduct is required.
• Strong organizational skills with proven experience in building strong, coherent and efficient teams.
• Solid reasoning and analytical skills.
• Experience in working in a decentralized system, and maintaining close working relationships with various departments, contractors, clinical centers and clinical and basic science laboratories.
• Excellent verbal and written communication skills.
• Proven ability to present programs to audiences ranging from high level scientists, clinical investigators and physicians, clinical trials execution teams and non-scientists is highly desirable.
• Experience working in a multicultural environment is required.
• Willingness to travel at least 20-25% of the time to IAVI regional and head offices required.
• Passion for the IAVI Mission.